Cough And Bronchial Daytime Syrup
FDA Label NDC 68466-1008

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Schwabe Mexico, S.a. De C.v. for the product Cough And Bronchial Daytime Syrup (NDC 68466-1008). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, inactive ingredient, dosage & administration, indications & usage, purpose, warnings, ask doctor, stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

ACONITUM NAPELLUS 3X

BRYONIA 3X

HEPAR SULPHURIS CALCAREUM 6C

SPONGIA TOSTA 3X

STANNUM METALLICUM 6C

Inactive Ingredient

citric acid

ethyl alcohol

gum arabic 

malt extract

purified water

sodium benzoate

sucrose

Dosage & Administration

Directions:

Shake well before each use.

Adults & children 12 years of age and older: Take 2 teaspoons (tsp) (10mL) every 2 hours.

For severe coughs, repeat every 20 minutes for first hour, then every 2 hours.

Children under 12 years of age: Consult a doctor.

Indications & Usage

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Soothes the throat.

Purpose

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Soothes the throat.

Warnings

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Ask Doctor

Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications.

Stop Use

Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persisitent headache.
These could be signs of a serious condition.

Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep Out Of Reach Of Children

Keep out of the reach of children

Overdose

In case of overdose, seek medical help or contact a Poison Control Center immediately.

* Please review the disclaimer below.